Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

cyclophosphamide

doxorubicin hydrochloride

conventional surgery

neoadjuvant therapy

thermal ablation therapy

William E. Gannon, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Combining chemotherapy with microwave thermotherapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy with or without microwave thermotherapy before surgery in treating women who have locally advanced breast cancer.

OBJECTIVES:

* Compare the safety and efficacy of neoadjuvant therapy comprising cytoreductive doxorubicin and cyclophosphamide with or without focused microwave thermotherapy in women with locally advanced breast cancer in an intact breast.
* Evaluate percentage of patients who achieve at least 85% pathological cell death after treatment with focused microwave thermotherapy.
* Compare clear pathology tumor margins and reduction of second incision rates in patients treated with these regimens.
* Compare the amount of surgically removed breast and tumor tissue in patients treated with these regimens.
* Compare the measurement of the extent of tumor margins in patients treated with these regimens.
* Compare the reduction of tumor size in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to tumor size (T2 vs T3). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive cyclophosphamide IV over 15 minutes and doxorubicin IV over 15 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.

During courses 1 and 2 only, patients undergo focused microwave thermotherapy on day 1 of chemotherapy (or within 36 hours after chemotherapy). Patients undergo ultrasound-guided placement of a microwave sensor and a temperature probe (before or after compression of the breast) and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast. Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue. In the absence of any unacceptable toxicity, a target tumor temperature of 43-47° C is reached and maintained for an equivalent thermal dose of 80-120 minutes.

* Arm II: Patients receive chemotherapy only as in arm I. Within 60 days after completion of thermochemotherapy or chemotherapy alone, patients in both arms undergo total mastectomy, partial mastectomy, or other breast-conserving surgery, as appropriate. At the discretion of the physician, beginning after completion of chemotherapy, patients in both arms who are estrogen receptor positive may receive oral tamoxifen. Within 4 weeks after completion of chemotherapy and surgery, eligible patients in both arms also undergo radiotherapy to the breast and lymph nodes.

Patients are followed at 30 and 90 days.

PROJECTED ACCRUAL: A total of 280-312 patients (140-156 per treatment arm) will be accrued for this study.

Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer

A Randomized Pivotal Clinical Trial To Assess The Efficacy Of Pre-operative Focused Microwave Thermotherapy Treatment Combined With Pre-operative Chemotherapy For Cytoreduction Of Advanced Breast Cacer In Intact Breast

Imunon

Symptoms and General Pathology

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Nervous System Diseases

Wounds and Injuries

Rare Diseases

Neoplasm Metastasis

Thyroid Diseases

Prostatic Neoplasms

Carcinoma

Sarcoma

Melanoma

Thyroid Neoplasms

Carcinoma, Renal Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Kidney Neoplasms

Spinal Cord Compression

Neoplasms, Unknown Primary

Neoplasms, Second Primary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Gastrointestinal Diseases

Spinal Cord Diseases

Central Nervous System Diseases

Spinal Cord Injuries

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

Adenocarcinoma

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Soft Tissue Sarcoma

Renal Cell Carcinoma

Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.

Computed Tomography

Quality-of-Life Assessment

Questionnaire Administration

Stereotactic Radiosurgery

Thermal Ablation Therapy

Jing Li

This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.

PRIMARY OBJECTIVE:

I. To document the rate of local control at 6 months in patients who receive a combination of thermal ablation and stereotactic spine radiosurgery (SSRS) for spine metastases with moderate to severe epidural involvement.

SECONDARY OBJECTIVES:

I. To determine local control at 1, 3, 9, 12, 18, and 24 months, and to compare to a historical control where patients received only SSRS at these time points and at 12 months.

II. To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months.

IIa. Calculate decrease in epidural tumor volume (by volumetric measurements). IIb. Calculate increase in thecal sac patency (by volumetric measurements and according to Bilsky method).

III. To determine overall survival at 6, 12, 18, and 24 months. IV. To assess changes in muscle strength, location and severity of spinal-related pain, sensory function, ability to ambulate, and neurological grading at 1, 3, 6, 9, 12, 18, and 24 months compared with pretreatment baselines.

V. To assess the effect of treatment on quality of life (QOL), measured at 1 month and every 3 months after with validated outcome measure tools.

VI. To describe adverse side effects after treatment and to descriptively correlate those effects with radiographic findings, pain control, and quality of life.

OUTLINE:

Patients undergo thermal ablation and computed tomography (CT)-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.

After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months.

Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord

A Phase II Clinical Trial Evaluating the Efficacy of Combining Thermal Ablation and Spine Stereotactic Radiosurgery for Patients With Spine Metastases With Moderate to Severe Epidural Involvement

Kaplan-Meier estimates will be used. Time to local failure will be monitored continuously using a Bayesian method. Cumulative incidence of local failure will be estimated failure treating death without failure as a competing risk. Propensity score analyses will be used to compare the thermal ablation cohort with a historical cohort where patients received only stereotactic spine radiosurgery (SSRS).

Extent of epidural tumor regression be determined by change in epidermal tumor volume and change in thecal sac patency (by volumetric measurements and according to Bilsky method). Kaplan-Meier estimates will be used. Cumulative incidence of epidural failure will be estimated failure treating death without failure as a competing risk. Propensity score analyses will be used to compare the thermal ablation cohort with a historical cohort.

The Physical exam includes general exam, (HEENT) Head, Eye, Ear, Nose and Throat evaluation, chest, heart, abdomen and extremities exam. Combined with the neurotically examination results, changes at 1, 3, 6, 9, 12, 18, and 24 months will be compared with pretreatment baselines. Patients with negative changes will be evaluated by the neurosurgeon and radiation oncologist to determine if the change is related to a local failure/complication or to progression of systemic disease. Kaplan-Meier estimates will be used.

The neurological exam includes (1) mental status (tested through history taking), (2) cranial nerves (Observation of eyes, face, voice, and coordination during history taking and as patient moves about the exam room. Look for extraneous movements), (3) motor system (visual inspection, tone, muscle strength and endurance, assigned score of 0-5 for each muscle, a score of 0 would mean no muscular contraction, and a score of 5 would mean movement against full resistance, normal strength), (4) reflexes, (5) sensory system (vibration in toes; pinprick in feet; (6) coordination (Truncal stability, fine finger movement, toe tapping, finger-nose-finger, heel-knee-shin), and (7) station and gait (Gait including arising from chair without hands, walking on toes, heels, and heel to toe). Kaplan-Meier estimates will be used.

Participants are asked to recall symptom severity and interference during the past 24 hours. Part I, The severity of the symptoms, including pain, fatigue, nausea, disturbed sleep, short of breath etc. Part II, How have the symptoms interfered with patient life, including mood, work, relations with other people etc. Part I, range 0-10. A score of 0 would mean the symptom is not present and a score of 10 means the symptom is as bad as you can imagine). Part II, range 0-10 (A score of 0 would mean the symptom did not interfere; A score of 10 means the symptom has interfered completely).

Participants are asked to assess the severity of pain and the impact of pain on daily functions. Severity of pain, including the pain location, worst pain in last 24 hours, least pain in last 24 hours, pain on average and pain right now. Range 0-10. A score of 0 would mean no pain and a score of 10 means the pain is as bad as you can imagine. Pain medications, amount of pain relief in the past 24 hours, and impact of pain on daily function, including general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life, and Range 0-10.

Participants are asked to twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). 3 and 5 point Likert scale is used in the survey. Two summary scores of the SF-12v2-physical and mental health-using the weighted means of the eight domains. Descriptive statistics will be used to summarize pain relief and quality of life at each follow-up visit, which will be the changes in scores from baseline to each assessment visit. Time to maximum pain relief will be the time from the day of thermal ablation until the lowest pain score for average pain after radiotherapy.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature.

PURPOSE: Randomized phase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of surgery alone in treating women who have stage I or stage II breast cancer.

OBJECTIVES:

* Compare the safety and efficacy of preoperative focused microwave thermotherapy followed by surgery vs surgery alone in women with early-stage primary breast cancer.
* Compare the reduction of tumor cells at surgical margins and second incision rates in women treated with these regimens.
* Compare the percentage of pathological cell death in women treated with these regimens.
* Compare the amount of surgically removed breast and tumor tissue in women treated with these regimens.
* Compare the measurement of the extent tumor margins of the surgically removed breast and tumor tissue in women treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to tumor classification (T1 vs T2) and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I:Patients undergo ultrasound-guided placement of a microwave sensor and a temperature probe (before or after compression of the breast) and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast. Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue. In the absence of undue heating of the skin, a tumor temperature of 48-52° C is targeted and maintained for an equivalent thermal dose of 140-180 minutes.

Within 60 days of thermotherapy, patients undergo lumpectomy.

* Arm II: Patients undergo lumpectomy only. Patients are followed at 30 and 90 days after surgery, and then at the discretion of the physician.

PROJECTED ACCRUAL: A total of 200-222 patients (100-111 per treatment arm) will be accrued for this study.

Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer

A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer	NCT00036985	Breast Cancer	cyclophosphamid... doxorubicin hyd... conventional su... neoadjuvant the... thermal ablatio...	18 Years -	National Cancer Institute (NCI)
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord	NCT02713269	Malignant Diges... Metastatic Head... Metastatic Kidn... Metastatic Mali... Metastatic Mali... Metastatic Mela... Prostate Carcin... Sarcoma Solid Neoplasm Spinal Cord Com... Stage IV Breast... Stage IV Lung N... Thyroid Gland C...	Computed Tomogr... Quality-of-Life... Questionnaire A... Stereotactic Ra... Thermal Ablatio...	18 Years -	M.D. Anderson Cancer Center
Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer	NCT00036998	Breast Cancer	conventional su... neoadjuvant the... thermal ablatio...	18 Years -	National Cancer Institute (NCI)

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